FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8113–8136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2023
SIRA™ RFA Electrosurgical Device
K232947 · GEI
Innoblative Designs, Inc.
General & Plastic Surgery · 83d
Cleared Dec 12, 2023
Insulia Bolus Companion
K232451 · NDC
Voluntis Sa.
Chemistry · 120d
Cleared Dec 12, 2023
Signature™ ONE System
K232425 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 123d
Cleared Dec 12, 2023
Ziehm Solo FD
K231669 · OWB
Ziehm Imaging GmbH
Radiology · 187d
Cleared Dec 12, 2023
Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™...
K230872 · MAX
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 257d
Cleared Dec 11, 2023
Nio Color 8MP (MDNC-8132)
K233693 · PGY
Barco N.V.
Radiology · 24d
Cleared Dec 11, 2023
FARADRIVE™ Steerable Sheath
K233248 · DRA
Boston Scientific Corporation
Cardiovascular · 74d
Cleared Dec 11, 2023
24HR513C
K232985 · PGY
Lg Electronics.Inc
Radiology · 80d
Cleared Dec 11, 2023
Wrist Blood Pressure Monitor
K232815 · DXN
Zhuhai Yueja Medical Device...
Cardiovascular · 89d
Cleared Dec 11, 2023
Hygenix
K232797 · FXX
Shenzhen Hygenix Industrial Co., Ltd.
General Hospital · 90d
Cleared Dec 11, 2023
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and...
K232303 · MBH
Depuy Ireland UC
Orthopedic · 132d
Cleared Dec 11, 2023
INTELLIO SHIFT System
K232290 · GEI
ArthroCare Corporation
General & Plastic Surgery · 132d
Cleared Dec 11, 2023
Transpara Density 1.0.0
K232096 · QIH
Screenpoint Medical B.V.
Radiology · 151d
Cleared Dec 11, 2023
iFlash-HCG
K223690 · DHA
Shenzhen Yhlo Biotech Co., Ltd.
Chemistry · 367d
Cleared Dec 11, 2023
EDS Calculus Softener TURBO CR
K223340 · ELC
Essential Dental Systems, Inc.
Dental · 405d
Cleared Dec 08, 2023
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical...
K233654 · JOJ
Steris
General Hospital · 24d
Cleared Dec 08, 2023
10F Sheath and Dilator Set
K233432 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 57d
Cleared Dec 08, 2023
Global Modular Replacement System
K233261 · JDI
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 70d
Cleared Dec 08, 2023
Vibrant System
K232830 · QTN
Vibrant, Ltd.
Gastroenterology & Urology · 86d
Cleared Dec 08, 2023
BTI Interna Prosthetic Components
K232750 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 91d
Cleared Dec 08, 2023
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port
K232737 · LJT
Bard Peripheral Vascular, Inc.
General Hospital · 92d
Cleared Dec 08, 2023
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302,...
K232517 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 112d
Cleared Dec 08, 2023
Valkyrie Thoracic Fixation System
K232515 · HRS
Jm Longyear Manufacturing, LLC D.B.A....
Orthopedic · 112d
Cleared Dec 08, 2023
DVAS (DVAS-M, DVAS-W)
K232085 · EHD
Genoray Co., Ltd.
Radiology · 148d